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Sponsors and Collaborators: |
Weill Medical College of Cornell University Genentech |
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Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00301418 |
This study will offer a safe treatment for patients with relapsing recurring glioblastoma (GBM) or anaplastic astrocytoma (AA). The trial will test the hypothesis that Erlotinib (Tarceva, OSI-774) can be safely used up to a dose of 150 mg two times a day for 12 months to ultimately enhance survival of patients with relapsed/refractory GBM/AA. Correlation of response to Tarceva with particular genetic alterations including epidermal growth factor receptor variant type III (EGFRvIII) amplification and phosphatase and tensin homolog (mutated in multiple advanced cancers 1) (PTEN) loss will be studied.
Condition | Intervention | Phase |
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Glioblastoma Multiforme Anaplastic Astrocytoma |
Drug: Erlotinib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Trial of Oral Erlotinib (Tarceva, OSI-774) for Treatment of Relapsed/Refractory Glioblastoma Multiforme and Anaplastic Astrocytoma |
Estimated Enrollment: | 43 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of tumors also exhibits the most aggressive behavior, resulting in median overall survival durations of only 9-12 months for GBM, and 3-4 years for AA, from initial diagnosis, despite multimodal treatment approaches. Initial therapy consists of either surgical resection, external beam radiation or both. The role of adjuvant or concomitant chemotherapy in the initial therapy of GBM and AA has not, as yet, been clearly defined. Since most of these patients experience a recurrence after first-line therapy, improvements in both first-line and salvage therapy are critical to enhancing quality-of-life and prolonging survival. In August 2003, the U.S. Food and Drug Administration (FDA) granted orphan drug status for Erlotinib in patients with malignant glioma. Erlotinib (OSI-774) has been shown to be active in a range of tumors including GBM, AA and non small cell lung cancer. Because of the promising results in preliminary studies of Erlotinib and because of significant experience with the safety of the dosages proposed in this study, this study will offer a safe adjuvant treatment for patients with relapsing recurring glioblastoma or anaplastic astrocytoma. Therefore, this phase I/II clinical research trial will test the hypothesis that Erlotinib can be safely used up to a dose of 150 mg bid for 12 cycles to ultimately enhance survival of patients with relapsed/refractory GBM/AA with particular genetic alterations including EGFRvIII amplification and PTEN loss.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Patients must have at least one confirmed and evaluable tumor site.*
*A confirmed tumor site is one which is biopsy-proven. NOTE: Radiographic procedures (e.g., Gd-enhanced MRI or computed tomography [CT] scans) documenting existing lesions must have been performed within three weeks of treatment on this research study.
Concomitant Medications:
Exclusion Criteria:
Contact: John A Boockvar, M.D. | 212-746-1996 | jab2029@med.cornell.edu |
Contact: Susan Pannullo, M.D. | 212-746-2436 | scp2002@med.cornell.edu |
United States, New York | |
The New York Hospital/ Weill Medical College | Recruiting |
New York, New York, United States, 10021 | |
Contact: John A. Boockvar, M.D. 212-746-1996 jab2029@med.cornell.edu | |
Contact: Susan Pannullo, M.D. 212-746-2436 scp2002@med.cornell.edu | |
Sub-Investigator: Theodore Schwartz, M.D. | |
Sub-Investigator: Philip Stieg, M.D. | |
Sub-Investigator: Susan Pannullo, M.D. | |
Principal Investigator: John A. Boockvar, M.D. |
Principal Investigator: | John A Boockvar, M.D. | Weill Medical College of Cornell University |
Responsible Party: | Weill Cornell Medical College ( John Boockvar MD ) |
Study ID Numbers: | 501007705 |
Study First Received: | March 9, 2006 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00301418 |
Health Authority: | United States: Institutional Review Board |
Glioblastoma Multiforme Anaplastic Astrocytoma High Grade Glial Neoplasms Brain Tumor |
Erlotinib Neuroectodermal Tumors Brain Neoplasms Glioblastoma Glioblastoma multiforme Astrocytoma |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Recurrence Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Neoplasms, Nerve Tissue |
Enzyme Inhibitors Neoplasms, Neuroepithelial Protein Kinase Inhibitors Pharmacologic Actions |